TGA approves AstraZeneca vaccine, Pfizer doses arrive in Aus

Tuesday, 16 February, 2021

TGA approves AstraZeneca vaccine, Pfizer doses arrive in Aus

The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca for its COVID-19 vaccine, meaning the vaccine can now be legally supplied in Australia. Initial supply of the vaccine will be imported into the country from overseas, with an ongoing supply set to be manufactured onshore.

COVID-19 Vaccine AstraZeneca is now included in the Australian Register of Therapeutic Goods (ARTG) for the active immunisation of individuals 18 years and older for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. It is the second COVID-19 vaccine to receive regulatory approval in Australia, following the TGA’s approval of Pfizer and BioNTech’s candidate last month.

While provisional approval of the vaccine is valid for two years, the approval is subject to certain strict conditions, such as the requirement for AstraZeneca to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment. The vaccine should also be used in accordance with official recommendations and given in two separate doses, the second to be administered a minimum of four weeks and optimally 12 weeks after the first.

While the vaccine has been shown to prevent COVID-19, it is not yet known whether it prevents transmission or just asymptomatic disease. Furthermore, while elderly patients over 65 years of age demonstrated a strong immune response (high seroconversion rates) to the vaccine in clinical trials, there were an insufficient number of participants infected by COVID-19 to conclusively determine the efficacy in this subgroup; efficacy has thus been inferred from immunogenicity data and efficacy demonstrated in the general population. With no safety concerns detected in this age group in clinical studies or in overseas rollouts, the TGA has deemed that the decision to immunise an elderly patient should be made on a case-by-case basis with consideration of their age, co-morbidities and environment taken into account.

The TGA’s approval coincides with the World Health Organization’s (WHO) decision to grant the vaccine Emergency Use Listing (EUL) for active immunisation to prevent COVID-19 in individuals 18 years of age and older, including those over 65. The EUL assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply, and also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. The EUL allows for two doses of the vaccine to be administered at a four- to 12-week interval, with the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommending a dosing interval of eight to 12 weeks.

The milestone also comes just one day after more than 142,000 doses of Pfizer and BioNTech’s COVID-19 vaccine arrived at Sydney Airport, in the first shipment of 20 million doses that have been secured as part of Australia’s COVID-19 Vaccine and Treatment Strategy. Pending batch testing from the TGA to ensure the vaccines meet Australia’s strict quality standards, Prime Minister Scott Morrison said the country is on track for the first group of Australians (Phase 1a) to start receiving the vaccine from 22 February.

“The vaccine has landed and we’re stepping up our fight against the pandemic,” the Prime Minister said.

“Once the final safety checks are completed, we can start rolling out the vaccine to our most vulnerable Australians and to our frontline border and health workers.”

Logistics company DHL has been engaged to support the distribution of the Pfizer vaccine across Australia. The company, along with a network of 200 ultralow-temperature portable freezers, will ensure Australians across the country, including in rural and remote areas, are able to access the Pfizer vaccine, which needs to be stored at -70°C.

Approximately 80,000 doses of the Pfizer vaccine will be released in the first week, 50,000 of which will be made available for the states and territories for hotel quarantine and border workers and frontline healthcare workers. Approximately 30,000 vaccines will be made available for the Commonwealth vaccine in-reach workforce to aged-care and disability-care residents. It is expected that at least 60,000 doses will be administered by the end of February, with these numbers set to double with the arrival of the AstraZeneca vaccine in early March. First-round doses for Phase 1a remain on track to be delivered within a six-week period, with second doses to be administered 21 days after the first dose.

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